Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that data from the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial was presented at the European Cancer Congress 2015 in Vienna, Austria. GALE-301 is Galena’s cancer immunotherapy that consists of a peptide (E39) derived from Folate Binding Protein (FBP). GALE-301 is combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) and administered via intradermal injection for the prevention of recurrence in ovarian and endometrial cancers.
Poster #P427 (abstract #2764), entitled “Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine GALE-301 (E39) + GM-CSF in ovarian and endometrial cancer patients to prevent recurrence,” provided updated data for all patients who have received at least twelve months of treatment. As presented, the clinical recurrence rate based on all treatment cohorts was 41% in the Vaccine Group (VG) (n=29) versus 55% in the Control Group (CG) (n=22), p=0.41. However, in the 1000 mcg VG cohort (n=15), there have only been two clinical recurrences (13.3% versus 55% CG, p=0.02), and the two-year Disease Free Survival (DFS) estimate is 85.7% (1000 mcg patients) versus 33.6% (CG), p < 0.02, as compared by Kaplan-Meir and Log rank tests.
“This one-year data from our GALE-301 trial is extremely encouraging as it has established the optimal dose while demonstrating clear signs of improvement in the disease free status of women with endometrial and ovarian cancer in the 1000 mcg cohort,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “More than 70,000 women will be diagnosed with ovarian or endometrial cancer this year, and we are focused on preventing their cancer from returning once they receive their initial treatments. Based on the data presented today, we expect to meet with the FDA to discuss a potential path forward to move GALE-301 into a prospective, randomized trial in ovarian and endometrial cancer patients to prevent recurrence.”
The clinical trial program for GALE-301 began as a Phase 1 3×3, safety and dose-escalation (100, 500, 1000 mcg of E39) trial and transitioned to a Phase 2a, expanding the optimal dose cohort. Disease-free endometrial and ovarian cancer patients were enrolled after receiving their standard of care therapy. HLA-A2+ patients were vaccinated (VG), and HLA-A2- patients followed prospectively as a CG. Six monthly intradermal inoculations of GALE-301 (E39) + 250 mcg GM-CSF were administered followed by two boosters, one every six months. A total of 51 patients were enrolled: 29 VG and 22 CG. Of the 29 VG patients, 15 received the optimal dose of 1000 mcg, and 14 patients received a suboptimal dose of less than 1000 mcg.
“The data presented at the European Cancer Congress reveal that E39 + GM-CSF is well tolerated and elicits a strong and dose-dependent in vivoimmune response. Early efficacy results are promising in the optimally dosed 1000 mcg cohort, with the vaccine exhibiting a very favorable safety profile with primarily Grade 1 and 2 toxicities and no differences in toxicities based on dose,” commented Julia Greene, M.D., post-doctoral fellow with the Cancer Vaccine Development Program, and the poster presenter.
Demographic, safety, immunologic, and clinical recurrence data are continuing to be collected. There have been no observable differences in age, grade, stage, or histology between groups (all p≥0.1). In vivo immunologic response is being measured by the delayed type hypersensitivity reaction (DTH) to the E39 peptide. DTH increased pre- to post-vaccination, and the DTH increase was larger in the patients who received the 1000 mcg dose. (Original Source)
Shares of Galena Biopharma closed last Friday at $1.65. GALE has a 1-year high of $2.39 and a 1-year low of $1.10. The stock’s 50-day moving average is $1.60 and its 200-day moving average is $1.58.
On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on August 7, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $5, which represents a potential upside of 203.0% from where the stock is currently trading. Separately, on the same day, Cantor Fitzgerald’s Mara Goldstein reiterated a Sell rating on the stock and has a price target of $2.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Mara Goldstein have a total average return of -16.7% and 4.1% respectively. Bernardino has a success rate of 24.7% and is ranked #3722 out of 3759 analysts, while Goldstein has a success rate of 43.5% and is ranked #1044.
Galena Biopharma Inc, is abiopharmaceutical company focused on developing and commercializing targeted oncology therapeutics that address medical needs across the full spectrum of cancer care.